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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000360-19 | EudraCT Number |
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This study is to determine the appropriate dosing regimen of GS-9820 in subjects with lymphoid malignancies. This is a Phase 1b, open-label, dose-escalation and expansion study evaluating the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of GS-9820.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GS-9820 | Experimental | Participants will be sequentially enrolled at progressively higher dose levels to receive GS-9820 administered twice a day. Escalation will proceed to the maximum tolerated dose (MTD), defined as the highest tested dose associated with a rate of dose-limiting toxicities (DLT) of < 33% during the first 4 weeks of therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GS-9820 | Drug | GS-9820 tablets containing 200 mg of GS-9820 administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose (MTD) | MTD will be assessed to determine the appropriate dosing regimens for use in future clinical trials of GS-9820 in subjects with lymphoid malignancies. | Up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overall safety | Overall safety will be assessed by overall safety profile, enumeration and description of any dose-limiting toxicities, serious adverse events, or adverse events leading to discontinuation of study drug. | Up to 5 years |
| Pharmacokinetic parameters of GS-9820 as measured by Cmax, Tmax, Ctrough, and AUC |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henry Adewoye, MD | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VU Medical Center (VUmc) | Amsterdam | 1081 HV | Netherlands | |||
| Academic Medical Center |
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| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D006689 | Hodgkin Disease |
| D020522 | Lymphoma, Mantle-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
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|
| Baseline to Day 29 |
| Pharmacodynamics to measure changes in the phosphatidylinositol 3-kinase (P13K) delta pathway activation and changes in plasma concentration of disease-associated chemokines and cytokines | Baseline to Day 29 |
| Tumor control | Tumor control as assessed by overall response rate (ORR), time to response (TTR), duration of response (DOR), progression-free survival (PFS), percent change in lymph node area, lymph node response rate, splenomegaly response rate, ALC response rate, hepatomegaly response rate, platelet response rate, hemoglobin response rate, and neutrophil response rate. | Up to 5 years |
| Patient well-being assessed using changes in baseline in HRQL (health related quality of life questionnaire) domain and symptom scores based on the Functional Assessment of Cancer Therapy: Lymphoma (FACT-Lym) | Up to 5 years |
| Drug exposure | Drug administration for GS-9820 as assessed by prescribing records and GS-9820 compliance as assessed by quantification of used and unused drug. | Up to 5 years |
| Amsterdam |
| 1105 AZ |
| Netherlands |
| St. Antonius Hospital | Nieuwegein | 3435 CM | Netherlands |
| Erasmus MC - Daniel den Hoed Cancer Center | Rotterdam | 3075 EA | Netherlands |
| D009369 |
| Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008223 | Lymphoma |